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Sponsored by: |
Viacor |
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Information provided by: | Viacor |
ClinicalTrials.gov Identifier: | NCT00568230 |
Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.
Condition | Intervention | Phase |
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Heart Failure Mitral Regurgitation |
Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open-Label, Single-Arm Feasibility Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty (PTMA) Device Used to Reduce Mitral Regurgitation. |
Enrollment: | 12 |
Study Start Date: | April 2006 |
Study Completion Date: | November 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patient is screened for study, and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
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Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Percutaneous access from right or left subclavian vein with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket.
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Ages Eligible for Study: | 50 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Viacor, Inc. ( Katharine M Stohlman ) |
Study ID Numbers: | 05-023P |
Study First Received: | November 30, 2007 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00568230 |
Health Authority: | Germany: Ethics Commission |
heart failure mitral regurgitation |
Heart Failure Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency |
Cardiovascular Diseases |